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CompletedNCT00253565Updated Apr 8, 2013

Imatinib Mesylate and Capecitabine in Treating Patients With Advanced Solid Tumors

A Phase 1 interventional study of capecitabine and imatinib mesylate in Unspecified Adult Solid Tumor, Protocol Specific, sponsored by Herbert Hurwitz. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-04-08.

Sponsored by Herbert Hurwitz · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
25
Ages
18 Years and older
Sex
All
01

Study summary

RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving imatinib mesylate together with capecitabine may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of imatinib mesylate when given together with capecitabine in treating patients with advanced solid tumors.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the maximum tolerated dose and recommended phase II dose of imatinib mesylate when administered with capecitabine in patients with advanced malignant solid tumors.

Secondary

  • Determine the non-dose-limiting toxic effects of this regimen in these patients.
  • Determine, preliminarily, the clinical activity of this regimen in these patients.
  • Determine the pharmacokinetics and pharmacogenetics of this regimen in these patients.
  • Determine, preliminarily, the effect of this regimen on wound angiogenesis in these patients.
  • Correlate pharmacokinetic parameters with clinical toxicity, clinical activity, or surrogate biomarker activity of this regimen in these patients.

OUTLINE: This is a dose escalation study of imatinib mesylate.

Patients receive oral capecitabine twice daily on days 1-14 and oral imatinib mesylate once or twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Cohorts of patients receive escalating doses of imatinib mesylate until the maximum tolerated dose is determined.

PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.

02

Conditions studied

  • Unspecified Adult Solid Tumor, Protocol Specific

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Keywords

  • unspecified adult solid tumor, protocol specific
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 25 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.

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Lead sponsor

Herbert Hurwitz is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed malignant solid tumors for which no standard effective therapy exists OR such therapy is refused
  • Previously treated brain metastases that are currently asymptomatic allowed

PATIENT CHARACTERISTICS:

Performance status

  • Karnofsky 70-100%

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count > 2,000/mm\^3
  • Platelet count > 100,000 mm\^3
  • Hemoglobin > 9.0 g/dL

Hepatic

  • Alkaline phosphatase \< 2.5 times upper limit of normal (ULN)
  • SGOT and SGPT \< 2.5 times ULN
  • Bilirubin \< 1.5 times ULN

Renal

  • Creatinine clearance > 50 mL/min

Cardiovascular

  • No congestive heart failure
  • No symptomatic coronary artery disease
  • No uncontrolled cardiac arrhythmias
  • No myocardial infarction within the past 12 months
  • No other clinically significant cardiac disease

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after completion of study treatment
  • No prior unanticipated severe reaction to fluoropyrimidine therapy
  • No known sensitivity to fluorouracil

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • More than 28 days since prior biologic therapy

Chemotherapy

  • More than 28 days since prior chemotherapy (42 days for nitrosoureas or mitomycin C)

Endocrine therapy

  • At least 90 days since prior steroids for the treatment of brain metastases
  • More than 28 days since prior hormonal therapy

Radiotherapy

  • At least 90 days since prior radiotherapy for the treatment of brain metastases
  • More than 28 days since other prior radiotherapy
  • No prior pelvic radiotherapy > 30% of the bone marrow

Surgery

  • More than 28 days since prior surgery and recovered
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Enrollment
25 participants (actual)

Interventions

  • Drugcapecitabine
  • Drugimatinib mesylate
06

Study locations

1 site
  • Duke Comprehensive Cancer Center
    Durham, North Carolina 27710, United States
07

References and documents

Publications

  • Dugan E, Truax R, Meadows KL, Nixon AB, Petros WP, Favaro J, Fernando NH, Morse MA, Blobe GC, Hurwitz HI. A phase I dose-escalation study of imatinib mesylate (Gleevec/STI571) plus capecitabine (Xeloda) in advanced solid tumors. Anticancer Res. 2010 Apr;30(4):1251-6. PubMed 20530436 ↗
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 8, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00253565
Lead sponsor
Herbert Hurwitz
Collaborators
National Cancer Institute (NCI)
Responsible party
Herbert Hurwitz (Associate Professor, Duke University) — Sponsor-investigator
First posted
Nov 15, 2005
Start date
Aug 2003
Primary completion
Jul 2006
Completion
Jul 2010
Last update
Apr 8, 2013

Study contacts

Herbert I. Hurwitz, MD
study chair · Duke Cancer Institute
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.

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